Rapid process development post clone selection to clinical production

Multiple tools are now available to decrease the time from molecule discovery to clinical trials. Platform approaches are one way to decrease timelines; however, sole reliance on a platform process risks sacrificing potential productivity gains in order to achieve this reduction.  In this study we compare the performance of a platform process for a mAb producing CHO cell line to one where media/feed and bioreactor development studies were performed. Several media/feed combinations where screened in addition to the platform process using a shake flask model.  The most promising non-platform media/feed combination was compared to the platform process in bioreactors where the non-platform combination showed superior productivity.  After an additional 12 bioreactor runs for process development, a two-fold increase in titer was obtained. With a typical platform processes requiring some degree of bioreactor development, the significant increase in productivity described here was achieved with only a modest impact on the development timeline.  The results of this study suggest that, while a useful tool for lessening time from molecule discovery to clinical trials, universal application of a platform approach to process development may come at the expense of value added improvements and that discretion should be exercised in regards to the unique requirements of each molecule related project.